Dalli seeks tougher rules on medicines information

John Dalli, the European commissioner for health and consumer policy, today proposed tighter controls on the information that the pharmaceutical industry can provide to the public on prescription medicines.

Under his proposals, only certain information on prescription-only medicines would be allowed, such as information on the label and on the packaging leaflets; information on prices; on clinical trials; or on instructions for use.

The channels for supplying information would be more closely limited. Only internet websites that are officially registered could be used, and printed information could be made available only when specifically requested by members of the public.

Companies would no longer be allowed to publish or sponsor publication in general print media.

All information would have to be checked to ensure it is of high quality, unbiased, evidence-based, factually correct, and understandable.

The checks would have to be carried out as a general rule by national health authorities, except in countries that have constitutional problems with potential censorship – notably Sweden and Denmark, where post-publication approval would be required.

The proposals are an update to the Commission’s proposal of December 2008, which Dalli has modified over the past year in the light of the critical views of the European Parliament.

In line with a Parliament resolution of November 2010, which accused the first draft of the legislation of leaning too far towards industry interests, the emphasis in the revised proposal is on empowering the patient. Dalli said: “The revised proposals put rights, interests and safety of patients first.”

The Commission is taking advantage of this update to EU rules to strengthen the current system for monitoring the safety of medicines too, in the wake of recent concerns over undisclosed adverse reactions to medicines.

Beuc, the European consumers’ organisation, welcomed the revision of “the original ill-conceived proposals”.

It saw the change as “a first tangible effect of the shift of competence on pharmaceutical policies” – which were moved away from the Commission’s enterprise department to its health department in 2010.

But it urged even greater tightening of the rules to avoid the risk that “the general public can be exposed to disguised advertising”.

Birgit Beger, secretary-general of the European doctors’ organisation, CPME, also welcomed the initiative. “The main source of information remains the healthcare professional through the privileged patient-doctor relationship,” she said.

The European Public Health Alliance insisted yesterday that the new rules “should not allow any type or form of activities that could be considered advertising and are currently prohibited”. It urged that authorities “be granted the necessary power and resources to punitively sanction companies that breach the ban with high financial fines”.